Humira Side Effects & Warnings

Humira is part of a class of biologics known as TNF blockers. These medications work by suppressing the immune system. While these drugs may be effective in treating symptoms of various inflammatory diseases, they also put users at greater risk of serious and even deadly infections and cancers.

A black box warning in Humira’s label highlights the risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens. It also features cancers, notably lymphoma and hepatosplenic T-cell lymphoma.

Common Side Effects

One of the most common side effects of Humira is a reaction at the injection site. The U.S. Food and Drug Administration received reports of more than 10,000 cases of injection-site reactions related to the medication in 2014. Injection-site reactions include redness, rash, swelling, itching or bruising. Symptoms typically go away within a few days. However, patients should call a doctor immediately if they have pain, redness or swelling around the injection site that doesn’t go away within a few days or gets worse.

Sinusitis and upper respiratory infections are among the most commonly reported side effects of Humira.

During clinical trials involving nearly 1,400 people, 17 percent of patients treated with Humira reported upper respiratory infection compared with 13 percent of people who received a placebo. Another 11 percent of Humira-treated patients reported sinusitis while only 9 percent of people given the placebo reported the condition.

Headache and rash were each reported by 12 percent of Humira-treated patients. Eight percent and 6 percent of placebo-treated patients reported headache and rash, respectively.

Side Effects

Humira (705 patients)

Placebo (690 patients)

Upper Respiratory Infection

17%

13%

Sinusitis

11%

9%

Headache

12%

8%

Rash

12%

6%

Other reported side effects were flu syndrome, nausea, abdominal pain, abnormal laboratory tests, high amounts of cholesterol in the blood, high levels of fat particles in the blood, blood in urine, increased alkaline phosphatase, accidental injury, back pain, urinary tract infection and hypertension.

Serious Infections

Serious and even fatal infections are a recognized risk of Humira. These serious infections may be caused by viruses, fungi or bacteria. They can spread throughout the body and may lead to hospitalization and death.

Fact

The risk of serious infection may be even greater in patients who use Humira at the same time as other biologics.

The risk of serious infection may be even greater in patients who use Humira at the same time as other biologics, including Orencia (abatacept), Kineret (anakinra), Remcade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol) or Simponi (golimuma). Some patients who were treated with rituximab (Rituxan) followed by TNF blockers also showed a higher rate of serious infections.

In addition to a tuberculosis (TB) warning, today’s Humira label carries a boxed warning for invasive fungal infections, such as histoplasmosis, as well as Legionella and Listeria infections. But that was not always the case. For years, Humira’s black boxed warning only included the risk of TB.

Tuberculosis (TB)

Humira’s black box warning clearly advises patients be tested for TB before starting Humira. Patients who test positive for TB should start treatment for the disease prior to starting Humira. Doctors should monitor all patients closely for signs and symptoms of TB during treatment with Humira, even if the initial latent TB test is negative.

“Cases of reactivation of tuberculosis and new onset tuberculosis infections have been reported in patients receiving Humira, including patients who have previously received treatment for latent or active tuberculosis,” according to the FDA.

Symptoms related to TB include a cough, fever, weight loss or loss of body fat and muscle. People considering Humira should let the prescribing doctor know if they have TB or have been in close contact with someone with TB. Also let the doctor know if the patient was born in, lives in or traveled to a place where there is more risk for getting TB.

Fact

In 2015, a Central Florida man filed a lawsuit, claiming he became paralyzed after using Humira.

According to the lawsuit, the man was given a shot of Humira and shortly thereafter began feeling numb from the waist down. He was then diagnosed with TB, according to the suit.

Invasive Fungal Infections

In September 2008, the FDA announced it would require makers of TNF blockers, like Humira, to highlight information about the risk of invasive fungal infections in a black box warning as well as in the warnings section of the drug’s prescribing information.

The agency notified health care professionals that it had received reports of people developing pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other infections while taking TNF blockers, such as Humira, and doctors were not consistently identifying the infections.

“In some patients, the diagnosis of histoplasmosis was initially unrecognized and antifungal treatment was delayed. Some of these patients died from histoplasmosis. There were also deaths in patients with coccidioidomycosis and blastomycosis.”

According to the FDA

Legionella and Listeria Bacteria

In September 2011, the FDA announced it had added information about infection with Legionella and Listeria bacteria to the black box warning for all TNF blockers, including Humira.

The agency explained it had identified cases of Legionella pneumonia in people treated with TNF blockers. The FDA searched its Adverse Event Reporting System and identified reports of 80 patients who developed Legionella pneumonia between 1999 and 2010 after taking Humira or other TNF blockers. At least 14 people died.

Close-up illustration of Legionella Pneumophila bacteria

In addition, the FDA searched English-language medical literature and identified case reports of 23 patients who developed Legionella pneumonia after being treated with TNF blockers. Four patients experienced severe pneumonia requiring mechanical ventilation; five patients received treatment in a hospital intensive-care unit and three patients died.

The FDA has also received reports of people taking TNF blockers and developing serious infections due to Listeria monocytogenes. The agency searched English-language medical literature and identified 26 published cases of Listeria infection in patients treated with TNF blockers. Infections included meningitis, bacteremia, endophthalmitis and sepsis. There were seven reported fatalities.

Many of the patients who developed Legionella pneumonia or Listeria infections had received immunosuppressive drugs, such as methotrexate and corticosteroids, at the same time as a TNF blocker.

Cancer

Children and adults taking Humira may have an increased risk of getting cancer. Specifically, patients taking TNF blockers have developed lymphoma, skin cancer (including basal cell and squamous cell) and leukemia. Some children, teenagers and young adults have developed hepatosplenic T-cell lymphoma, a rare, often fatal cancer of white blood cells.

Lymphomas, Leukemia and Melanoma

In June 2008, the FDA announced it was investigating 30 reports of cancer in children and young adults who were treated with TNF blockers for Juvenile Idiopathic Arthritis, Crohn’s disease or other diseases.

Fact

Use of TNF blockers is associated with an increased risk of lymphoma and other cancers in children and adolescents.

Reports of cancer were submitted to the FDA’s Adverse Event Reporting System over 10 years, beginning in 1998 — after the first TNF blocker hit the market — through April 29, 2008. The cases involved children and young adults who took TNF blockers with methotrexate, azathioprine or 6-mercaptopurine.

About half the cancers were lymphomas, including both Hodgkin’s and non-Hodgkin’s lymphoma; other cancers reported included leukemia, melanoma and solid organ cancers.

In a follow-up announcement in August 2009, the FDA said it had completed its analysis and concluded that there is an increased risk of lymphoma and other cancers associated with the use of TNF blockers in children and adolescents. The agency added the new safety information to the boxed warning for Humira and the other TNF blockers.

In addition, the FDA added new warnings about leukemia and new-onset psoriasis in patients treated with TNF blockers.

Hepatosplenic T-cell Lymphoma

The FDA put out two alerts in 2011 regarding TNF blockers and the development of cancer. First, in April, the FDA said it continued to receive reports of hepatosplenic T-cell lymphoma (HSTCL).

The reports were primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with TNF blockers as well as azathioprine and/or mercaptopurine. One patient was being treated for psoriasis and two patients were being treated for rheumatoid arthritis.

The FDA reviewed data from the Adverse Event Reporting System database, literature and the HSTCL Cancer Survivors’ Network and identified two cases of HSTCL with Humira and five cases with the combination of Humira and Remicade.

The cases were reported between the time TNF blocker marketing started and December 31, 2010. Of the five cases identified with the combination of Remicade and Humira use, four involved concomitant use of mercaptopurine or azathioprine.

FDA Announces ‘Enhanced Safety Surveillance’ for Humira

In a second 2011 safety communication, the FDA announced that it is requiring manufacturers of TNF blockers to “perform enhanced safety surveillance” for TNF blockers.

Enhanced surveillance allows the FDA to more completely capture and analyze malignancies in pediatric patients

As part of the enhanced safety surveillance, manufacturers must conduct in-depth follow-up of reports of cancer cases and submit all reports of cancer in pediatric and young adult patients to the FDA within 15 days of becoming aware of the report. The manufacturers must also provide annual summaries and assessments.

“This type of safety surveillance is important for our improved understanding of malignancies in pediatric and young adult patients treated with TNF blockers because it will allow [the] FDA to more completely capture and analyze all reported malignancies based on more complete and consistent reports,” the FDA said.

The agency says it will periodically re-evaluate the enhanced surveillance requirement through 2021.

In a study of Humira in children with Juvenile Idiopathic Arthritis, 6 percent of patients suffered allergic reactions — including allergic rash — within the first 48 weeks of treatment. About 5 percent of patients in a study of Humira in children with Crohn’s disease suffered allergic reactions.

Signs of a serious allergic reaction include hives, trouble breathing, and swelling of the face, eyes, lips or mouth. Patients should call their doctor or get medical help immediately if they experience symptoms of an allergic reaction.

Hepatitis B Reactivation

People who carry hepatitis B virus (HBV) in their blood should be extra cautious when deciding whether to use Humira because the virus can become active during treatment.

“In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal,” according to Humira’s label. “The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation.”

Patients should undergo blood tests before, during and for several months after treatment with Humira.

It’s important to let the prescribing doctor know if the patient suffers from any of the following symptoms of a possible hepatitis B infection:

Muscle aches

Clay-colored bowel movements

Feeling very tired

Fever

Dark urine

Chills

Skin or eyes look yellow

Stomach discomfort

Little or no appetite

Skin rash

Vomiting

Neurological Reactions

Humira’s label warns consumers that the medicine has been associated with central and peripheral nervous system demyelinating disease. This includes multiple sclerosis (MS), optic neuritis and Guillain-Barré syndrome.

Some people experienced symptoms of these disorders for the first time following Humira use; others suffered from worsening of symptoms they already had.

“Exercise caution in considering the use of HUMIRA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders,” the Humira label states.

Blood Reactions

Though rare, some people have experienced blood reactions with use of TNF blockers, including Humira.

Humira’s label specifically warns of reports of pancytopenia, a condition in which the body has too few red blood cells, white blood cells and platelets.

Blood reactions reported with TNF use include:

Aplastic anemia

not enough new blood cells

Thrombocytopenia

not enough platelets in the blood

Leukopenia

not enough white blood cells

Signs and symptoms that may indicate blood dyscrasias or infection include persistent fever, bruising, bleeding and pallor. Anyone who experiences these symptoms while using Humira should contact a doctor.

Heart Failure

The drug’s label warns of cases of worsening congestive heart failure (CHF) with Humira, though the medicine has not been formally studied in patients with the condition.

Fact

Though the drug has not been formally studied in patients with the condition, Humira’s label warns of cases of worsening congestive heart failure.

Other Humira Warnings

Humira may cause immune reactions, including a lupus-like syndrome. Symptoms may improve when patients stop taking Humira, though they should not stop treatment without consulting a doctor. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain or a rash on the cheeks or arms that gets worse in the sun.

In addition, liver problems — including ones that can lead to liver failure and death — can happen in people who use TNF blockers, such as Humira. Symptoms of liver problems include fatigue, yellow-looking skin or eyes, poor appetite or vomiting, and pain on the right side of your stomach.

Some Humira users suffered new psoriasis or worsening of psoriasis they already had. Signs of psoriasis include red scaly patches or raised pus-filled bumps.

Please seek the advice of a medical professional before making health care decisions.

Emily Miller is an award-winning journalist with 7 years of professional experience writing and editing content for reputable media organizations across the U.S. She also has 13 years of personal experience as a patient living with Crohn’s disease. Her coverage of U.S. prescription drug prices for Drugwatch has been published or cited by news outlets, including The Hill, Fox Business and United Press International. Some of her qualifications include:

Society of Professional Journalists and The Alliance of Professional Health Advocates member

Centers for Disease Control and Prevention Health Literacy certificates

2016 Florida Society of News Editors third place winner in Breaking News

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